Product Description
Revefenacin, a once-daily long-acting muscarinic antagonist for nebulization recently approved by the US FDA for the treatment of patients with COPD, was discovered and developed using "duration and lung selectivity-by-design." This strategy selected a molecule with a high lung-selective index to maximize bronchodilation and limit systemic anti-muscarinic side effects. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/31908443/)
Mechanisms of Action: mAChR Antagonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral,Inhalant,Intravenous
FDA Designation: *
Approval Status: Approved
Approved Countries: Egypt | Lebanon | Philippines | Saudi Arabia | Singapore | United Arab Emirates | United States
Approved Indications: None
Known Adverse Events: None
Company: VIATRIS & KG
Company Location:
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: China, United States
Active Clinical Trial Count: 3
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Chronic Obstructive Pulmonary Disease
Phase 2: Respiratory Insufficiency
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| RARICO | P2 |
Recruiting |
Respiratory Insufficiency|Chronic Obstructive Pulmonary Disease |
2025-04-01 |
12% |
2024-12-13 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
| CTR20212308 | P3 |
Completed |
Chronic Obstructive Pulmonary Disease |
2023-07-26 |
2025-04-29 |
Patient Enrollment|Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |
|
| REV-3001 | P3 |
Completed |
Chronic Obstructive Pulmonary Disease |
2023-07-26 |
42% |
2023-08-19 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
06/02/2025 |
News Article |
Theravance Biopharma, Inc. Sells Remaining Royalty Interest in Trelegy Ellipta to GSK for $225 Million |
|
05/13/2025 |
News Article |
Theravance Biopharma to Participate in an Upcoming Investor Conference |
|
05/09/2025 |
News Article |
Theravance Biopharma Announces Ampreloxetine Presentations at the International MSA Congress |
|
04/28/2025 |
News Article |
Theravance to Present Analyses of Ampreloxetine and Neurogenic Orthostatic Hypotension at the 2025 International MSA Congress |